EN ISO 8537-2016 en Sterile single-use syringes with or without needle for insulin《胰岛素用有或无针头一次性无菌注射器》.pdf

1、BSI Standards PublicationBS EN ISO 8537:2016Sterile single-use syringes, withor without needle, for insulinBS EN ISO 8537:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 8537:2016.It supersedes BS EN ISO 8537:2008 which is withdrawn. The UK participatio

2、n in its preparation was entrusted to TechnicalCommittee CH/84, Catheters and syringes.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for it

3、s correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 85304 3ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and St

4、rategy Committee on 30 April 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8537 April 2016 ICS 11.040.20 Supersedes EN ISO 8537:2008English Version Sterile single-use syringes, with or without needle, for insul

5、in (ISO 8537:2016) Seringues insuline, striles, non rutilisables, avec ou sans aiguille (ISO 8537:2016) Sterile Insulin-Einmalspritzen mit oder ohne Kanle (ISO 8537:2016) This European Standard was approved by CEN on 27 February 2016. CEN members are bound to comply with the CEN/CENELEC Internal Reg

6、ulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN mem

7、ber. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

8、CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland

9、, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in

10、 any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8537:2016 EBS EN ISO 8537:2016EN ISO 8537:2016 (E) 3 European foreword This document (EN ISO 8537:2016) has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and cat

11、heters“ in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2016, and

12、 conflicting national standards shall be withdrawn at the latest by October 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This

13、 document supersedes EN ISO 8537:2008. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an

14、 integral part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav R

15、epublic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. The following referenced documents are indispensable f

16、or the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check that

17、 any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if

18、 available, and otherwise to the dated version of the ISO or IEC standard, as listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. BS EN ISO 8537:2016EN ISO 8537:2016 (E) 4 Table Correlatio

19、n between normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO or IEC ISO 594-1 EN ISO 594-1:1986 ISO 594-1:1986 ISO 7864 EN ISO 7864:1995* ISO 7864:1993* ISO 9626 EN ISO 9626:1995* ISO 9626:1991* ISO 1497

20、1 EN ISO 14971:2012 ISO 14971 ISO 62366-1 EN ISO 62366-1:2015 IEC 62366-1:2015 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2003 ISO 80369-7 EN ISO 80369-7:2016* ISO 80369-7:2016* * New versions expected end of 2015.* Expected 2016. Endorsement notice

21、The text of ISO 8537:2016 has been approved by CEN as EN ISO 8537:2016 without any modification. BS EN ISO 8537:2016EN ISO 8537:2016 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC This

22、 European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to the Essential Requirements of Directive 93/42/EEC. Once this standard is cited in the Official Journal of the European Union under

23、that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements

24、of that Directive and associated EFTA Regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced as far

25、as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the

26、Directive. NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard.

27、Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/subclause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 5.1 m 7.1 6.1.2 c, 6.1.3 c, 6.2 b 7.2 5.2, 5.4 7.3 5.11.2, 5.11.3 7.5 6.1 7.6 6.1.2, 6.1.3, 7

28、.2.2, 7.3, 7.4 8.3 5.1 n 8.4 5.1, 5.4, 5.6, 5.7, 7.3 g, 7.4 h, 7.5 h, 7.6 f 9.2 5.1 e, 5.1 g 10.1 5.1 e, 5.2 10.2 5.1 f 10.3 BS EN ISO 8537:2016EN ISO 8537:2016 (E) 6 Clause 7 13.1 Clause 7 13.2 7.2.1, 7.2.2, 7.3, 7.4, 7.5, 7.6, 7.7 13.3 7.2.1 b, 7.3 e, 7.4 g 13.4 7.4, 7.5, 7.6 13.6 The information

29、is provided on the packaging and no additional instruction for use is required WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 8537:2016ISO 8537:2016(E)Foreword vIntroduction vi1 Scope . 12 Normative referenc

30、es 13 Terms and definitions . 24 Types of syringes 55 Requirements 55.1 General requirements . 55.2 Material selection . 65.3 Colour coding . 65.4 Extraneous matter . 75.4.1 General 75.4.2 Limits for acidity or alkalinity 75.4.3 Limits for extractable metals. 75.5 Lubrication . 75.5.1 Lubrication of

31、 syringes . 75.5.2 Lubrication of needle tube 85.6 Dimensions . 85.6.1 Barrel and plunger stopper 85.6.2 Finger grips 85.7 Plunger/plunger stopper . 85.7.1 General 85.7.2 Fit of plunger stopper in barrel . 85.8 Nozzle 85.8.1 Conical fitting 85.8.2 Position of nozzle on end of barrel . 85.9 Needle tu

32、bing and needles . 95.9.1 Needles for syringe types 3 and 4 . 95.9.2 Needle tubing for syringe types 5, 6, 7 and 8 95.9.3 Bond between hub and needle tube . 95.10 Standard test environmental conditions 95.11 Performance of assembled syringe . 95.11.1 Dead space 95.11.2 Freedom from leakage at needle

33、 . 105.11.3 Freedom from leakage past plunger stopper .106 Packaging 106.1 Unit packaging and self-contained syringe units .106.1.1 General. 106.1.2 Unit packaging providing sterile barrier syringes (types 1, 3, 5 and 7) .106.1.3 Self-contained syringes with sterile interiors (types 2, 4, 6 and 8) 1

34、06.2 Multiple-unit packaging (for syringe types 2, 4, 6 and 8) .116.3 User packaging . 117 Information supplied by the manufacturer 117.1 General 117.2 Syringes 117.2.1 General. 117.2.2 Additional marking for self-contained syringes (syringe types 2, 4, 6 and 8) .127.3 Unit packaging (for syringe ty

35、pes 1, 3, 5 and 7) 127.4 Multiple unit packs (syringe types 2, 4, 6 and 8) .127.5 User packaging . 137.6 Storage container . 147.7 Transport wrapping 14 ISO 2016 All rights reserved iiiContents PageBS EN ISO 8537:2016ISO 8537:2016(E)Annex A (normative) Fluid for determination of acidity/alkalinity a

36、nd extractable metals .15Annex B (normative) Test method for air leakage past syringe piston during aspiration and for separation of rubber stopper and plunger .16Annex C (normative) Test method for determination of forces required to operate piston .18Annex D (normative) Test method for determinati

37、on of dead space 20Annex E (normative) Test method for liquid leakage at syringe piston and syringe nozzle/hub or needle/barrel unions during compression 21Annex F (normative) Test method for air leakage past nozzle/hub or needle/barrel unions during aspiration 23Annex G (normative) Preparation of e

38、xtract for test for pyrogenicity and toxicity .24Annex H (normative) Syringe sizes and graduated scales 25Bibliography .27iv ISO 2016 All rights reservedBS EN ISO 8537:2016ISO 8537:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards

39、 bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organiza

40、tions, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its furt

41、her maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directiv

42、es).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Int

43、roduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to

44、conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.The committee responsible for this document is ISO/TC 84, Devices for administration of medicinal products and

45、 catheters.This third edition cancels and replaces the second edition (ISO 8537:2007), which has been technically revised to include the following changes:a) revised the introduction;b) revised the scope to include various concentrations of insulin, specified plastic materials and excluded, e.g. sin

46、gle-use syringes made of glass;c) added some normative references;d) added new definitions;e) added new colour codes for higher concentration of insulin;f) clarified the drawing to illustrate the component of the syringe;g) included general requirements;h) revised test methods for syringes;i) revise

47、d the labelling requirement;j) moved the syringe sizes and graduated scales in Annex H;k) deleted Annex I. ISO 2016 All rights reserved vBS EN ISO 8537:2016ISO 8537:2016(E)IntroductionThis International Standard covers insulin syringes primarily intended for human use and provides performance and te

48、sting requirements. It permits broader variation in design so as to not limit innovation in technology or methods of packaging. Its appearance and layout are consistent with other TC 84 International Standards, which are designed to be more performance-based than design-prescriptive.Manufacturers ar

49、e expected to follow a risk-based approach and employ usability engineering during the design, development and manufacture of insulin syringes.This edition introduces general requirements as design guidelines for manufacturers. This edition retains a number of limits on requirements, which were originally based on consensus opinion but subsequently have been confirmed in practice.This International Standard does not specify materials to be used for the construction and lubrication of sterile insulin syringes and needles for single use because th